Bristol-Myers Squibb’s Opdivo will be available on the NHS for squamous cell carcinoma of the head and neck after all, following a u-turn by the National Institute for Health and Care Excellence.
The cost watchdog has backed funding for the immunotherapy via the Cancer Drugs Fund, for patients who have not responded to chemotherapy within six months, and the cancer has spread to other parts of the body.
Initial preliminary guidelines had rejected Opdivo (nivolumab) after deeming its cost effectiveness uncertain. The new deal allows patients access via the CDF to allow for more clinical data on the drug to be collected, to give a clearer idea of whether is offers value for money.
Current clinical trial evidence shows that the drug extends life by more than three months compared to current treatments, NICE said.
“Nivolumab is an innovative drug that continues to draw attention, but its clinical evidence for some types of cancer can be uncertain,” noted Professor Carole Longson, director of the Centre for Health Technology Evaluation at NICE.
“I am pleased the company has worked with us and NHS England to develop a managed access agreement and that we have found a way to provide for patients despite these uncertainties.”
“I am delighted that doctors will now be able to offer nivolumab to patients with advanced head and neck cancer. The disease is extremely debilitating, with no effective treatment options where chemotherapy has failed,” commented Professor Kevin Harrington, Professor of Biological Cancer Therapies at The Institute of Cancer Research, London, and consultant clinical oncologist at The Royal Marsden NHS Foundation Trust.
“I’m pleased that NICE have shown flexibility in allowing access to nivolumab through the Cancer Drugs Fund for two years while more data is collected - including on whether we can predict in advance who will benefit from treatment. Immunotherapy is extremely expensive and it is essential that future trials are designed to assess the effectiveness of biomarkers to target treatment, so we only use it in patents who are likely to respond.”
Professor Paul Workman, chief executive of The Institute of Cancer Research, London, also welcomed the decision, but added: “it’s frustrating that it has once again come after a six-month delay following the drug’s initial rejection.
“We seem to have slipped into a kind of game where exciting new treatments are routinely priced too high initially, and NICE is forced to turn them down on first assessment. The losers in this game are patients, and for some people with head and neck cancer today’s decision will have come too late.”
There are almost 10,000 cases of newly diagnosed head and neck cancer in the UK every year. An estimated 900 patients are expected to receive Opdivo during the managed access period on the CDF.